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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EHepatitis C virus genotype (GT)-3 is common worldwide and is accompanied by a significant disease burden. Among patients with cirrhosis, it is associated with increased risk of fibrosis progression, steatosis, and hepatocellular carcinoma. The Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV [ALLY-3; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT02032901\u0026amp;atom=%2Fspmdc%2F14%2F48%2F12.atom\u0022\u003ENCT02032901\u003C\/a\u003E] trial evaluated the efficacy and safety of daclatasvir plus sofosbuvir in patients chronically infected with GT-3.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ELiver Conditions\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EViral Infections Hepatology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ELiver Conditions\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EViral Infections\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EHepatitis C virus (HCV) genotype (GT)-3 is common worldwide and is accompanied by a significant disease burden [Pol S et al. \u003Cem\u003ELiver Int.\u003C\/em\u003E 2014]. Among patients with cirrhosis, it is associated with increased risk of fibrosis progression, steatosis, and hepatocellular carcinoma [Nkontchou G et al\u003Cem\u003E. J Viral Hepat\u003C\/em\u003E. 2011; Larsen C et al. \u003Cem\u003EJ Med Virol\u003C\/em\u003E. 2010; Bochud PY et al. \u003Cem\u003EJ Hepatol\u003C\/em\u003E. 2009]. Current treatment options are limited and require 24-week treatment that includes ribavirin. Results of the Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV [ALLY-3; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT02032901\u0026amp;atom=%2Fspmdc%2F14%2F48%2F12.atom\u0022\u003ENCT02032901\u003C\/a\u003E] trial presented by David R. Nelson, MD, University of Florida, Gainesville, Florida, USA, show that oral therapy with the combination of daclatasvir (DCV) and sofosbuvir (SOF) achieves high rates of sustained viral response up to 12 weeks after therapy (SVR12).\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EALLY-3 was a phase 3 trial that evaluated the efficacy and safety of DCV plus SOF in patients chronically infected with GT-3. In this open-label trial, patients received oral DCV 60 mg plus oral SOF 400 mg twice daily for 12 weeks. The primary end point was SVR12 (HCV RNA \u0026lt; lower limit of assay quantification [LLOQ]). The study included treatment-na\u00efve (n = 101) and treatment-experienced (n = 51) adult patients with chronic GT-3 infection and HCV RNA \u2265 10 000 IU\/mL. Patients previously treated with NS5A inhibitors were excluded.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EOverall, patients had a mean age of approximately 55 years. About two-thirds were men and the majority were white. Between 69% and 75% of the participants had a high viral load (\u0026gt; 800 000 IU\/mL) and approximately 21% were cirrhotic as defined by the protocol. About 60% of the participants were non-CC IL28B GT. In the experienced group, about 61% of participants had relapsed, 14% had a null response, and 4% had a partial response. The cause of treatment failure in the remaining 22% was \u201cother.\u201d Seven patients in the experienced group had received prior treatment with SOF; 2 were treated with alisporivir.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003ETreatment with DCV plus SOF was associated with a high rate of SVR12 in both groups (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/48\/12\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Primary End Point: Sustained Viral Response to Treatment 12 Weeks After Therapy\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1257558111\u0022 data-figure-caption=\u0022Primary End Point: Sustained Viral Response to Treatment 12 Weeks After Therapy\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/48\/12\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/48\/12\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/48\/12\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15566\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003EPrimary End Point: Sustained Viral Response to Treatment 12 Weeks After Therapy\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EError bars indicate 95% confidence intervals. SVR12, sustained viral response to treatment 12 weeks after therapy.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003E\n            \u003Csup\u003Ea\u003C\/sup\u003EHepatitis C virus RNA \u0026lt; lower limit of quantification (25 IU\/mL).\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-3\u0022\u003EReproduced with permission from DR Nelson, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-7\u0022\u003E\n         \u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E shows the on-treatment virologic response at week 4 and at the end of treatment for target not detected or target below the level of quantification. By the end of treatment, all but 1 patient were virus negative. Week-4 viral levels did not predict response vs nonresponse.\u003C\/p\u003E\u003Cdiv id=\u0022F2\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/48\/12\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022On-Treatment Virologic Response\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1257558111\u0022 data-figure-caption=\u0022On-Treatment Virologic Response\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/48\/12\/F2.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/48\/12\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/48\/12\/F2.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15567\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \n            \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003EOn-Treatment Virologic Response\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-4\u0022\u003EHCV, hepatitis C virus; LLOQ, lower limit of quantification; SVR12, sustained viral response to treatment 12 weeks after therapy.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-5\u0022\u003E\n            \u003Csup\u003Ea\u003C\/sup\u003EUndetectable HCV RNA or HCV RNA \u0026lt; LLOQ (25 IU\/mL).\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-6\u0022\u003E\n            \u003Csup\u003Eb\u003C\/sup\u003ESVR12 rates based on week 4 HCV RNA levels: \u0026lt; LLOQ, target detected, 86%; \u0026lt; LLOQ, target not detected, 91%.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-7\u0022\u003EReproduced with permission from DR Nelson, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-9\u0022\u003ESVR12 rates were not influenced by sex, age \u0026lt; vs \u2265 65 years, HCV RNA levels, or IL28B polymorphism (CC vs non-CC). Cirrhosis did have a significant influence, regardless of prior treatment status. Overall, only 63% of patients with cirrhosis achieved SVR12 compared with 96% of patients without cirrhosis; rates were similar for treatment-na\u00efve and experienced patients. Among patients with cirrhosis, 34% had portal hypertension (as assessed by platelet counts \u0026lt; 100 000\/mm\u003Csup\u003E2\u003C\/sup\u003E). Sixteen patients relapsed; 11 of those had cirrhosis. The most common adverse events (\u0026gt; 10% of patients) were headache, fatigue, and nausea; none led to discontinuation.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EThe combination of DCV plus SOF was safe, well tolerated, and associated with SVR12 rates as high as 96% in patients without cirrhosis. There were no virologic breakthroughs. The resistance analysis for this study is ongoing.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/48\/12.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzof32\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzof32\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}